Identity
- Trade Name
- Polycryl FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A5108 model consists of a 5/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both the ends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are Spatula. FDA UDI
- Model / Reference
- A5108 FDA UDI
- Description
- Absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and PGA suture. A5108 model consists of a 5/0 PGA suture of length 45cm attached with two 330 microns SS needles having the needle length of 8.0mm in both the ends of suture. Angle of curvature of both the needles are 90° [1/4 Circle]. Point profile of both needles are Spatula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803878041638 FDA UDI
- 510(k) Number
- FDA Product Code
- GAM FDA 510(k)FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4493 FDA 510(k)
- Regulation Number
- 878.4493 FDA 510(k)FDA UDI
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Polycryl by Aurolab — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140039 | Class II | Active |
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Manufacturer
- Manufacturer
- Aurolab
Sources (2)
- FDA 510(k) K140039 24 fields · synced Jun 18, 2026
- FDA UDI 0a6cfed5-0ebd-4a3d-88ab-7f03a6c25670 36 fields · synced May 27, 2026